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October 10, 2011Information needed when submitting unlisted drug codes
In compliance with HIPAA requirements when submitting an unlisted injection code, such as the therapeutic
injection codes 96379
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Who needs final unlisted drug codes?
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Final unlisted drug codes are required by pharmaceutical companies or healthcare providers who have developed or are using drugs that do not have a specific code or classification in the existing drug code system.
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These codes are necessary for proper identification, tracking, and reimbursement purposes.
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What is final unlisted drug codes?
Final unlisted drug codes are unique identifiers assigned to drugs that do not have a specific National Drug Code (NDC) and are not listed in any published drug compendium.
Who is required to file final unlisted drug codes?
Manufacturers, repackagers, relabelers, and distributors of drugs are required to file final unlisted drug codes.
How to fill out final unlisted drug codes?
Final unlisted drug codes can be filled out electronically through the FDA's online submission portal or through paper forms provided by the FDA.
What is the purpose of final unlisted drug codes?
The purpose of final unlisted drug codes is to track and monitor drugs that do not have a specific NDC to ensure patient safety and regulatory compliance.
What information must be reported on final unlisted drug codes?
Final unlisted drug codes must include information such as drug name, strength, dosage form, package size, and manufacturer information.
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